Development and Deployment of an Electrochemical Antigen Testing System for SARS-CoV-2

SARS-CoV-2 电化学抗原检测系统的开发和部署

• 批准号: 10195248
• 负责人: Shana O Kelley
• 金额: $ 29.59万
• 依托单位: UNIVERSITY OF TORONTO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10195248
• 关键词: 2019-nCoV; Aerosols; American; Antibodies; Binding; Biological; Biological Assay; Biological Markers; COVID-19; COVID-19 assay; COVID-19 detection; COVID-19 pandemic; COVID-19 patient; Clinical Research; Collaborations; Collection; Communicable Diseases; Communities; Complex; Data; Decentralization; Detection; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diffusion; Disease; Disease Outbreaks; Electrochemistry; Electrodes; Engineering; Future; Generations; Home; In Situ; Individual; Infection; Laboratories; Lateral; Liquid substance; Measurement; Methods; Molecular; Motion; Nature; Nucleic Acids; Oral cavity; Patient Monitoring; Population; Process; Rapid screening; Reagent; Research Personnel; SARS-CoV-2 infection; SARS-CoV-2 spike protein; Saliva; Sampling; Signal Transduction; Specificity; Surface; System; Systems Development; Technology; Testing; Time; United States; Universities; Validation; Viral; Viral Load result; Viral Proteins; Virus; Virus Diseases; antibody test; antigen test; base; biosafety level 3 facility; combat; cost; cost effective; design; detection assay; detection platform; effective intervention; infection rate; influenzavirus; instrument; low and middle-income countries; medical countermeasure; mortality; mouse model; multidisciplinary; nasopharyngeal swab; new technology; novel; pandemic disease; particle; pathogenic virus; point of care; portability; prevent; prototype; rapid testing; response; saliva analysis; saliva sample; screening; sensor; tool; viral detection

Project Summary: The COVID-19 pandemic has highlighted the shortcomings of existing testing approaches for viral infection. Diagnosing active infections using PCR or other amplification strategies is constrained to centralized testing facilities that have limited capacity. New point-of-care molecular testing approaches, while providing a means to test outside of laboratories, have low throughput and turnaround times that are not compatible with widespread, rapid screening. Moreover, the use of nasopharyngeal swabs is highly problematic given the difficultly of acquiring and processing this sample type. Antibody tests integrated into lateral flow devices utilize a more tractable sample type and are effective for estimating infection rates, but are not useful for detecting active infections. In this proposal we describe a new viral detection approach that is rapid, amenable to massively decentralized testing, and provides a new means to perform viral infection assessment as a tool to combat the current COVID-19 pandemic and control future viral outbreaks. The new technology powering this approach is a breakthrough in reagentless sensing accomplished using electrochemical readout that will enable rapid screening for SARS-CoV-2 infection. The sensors will directly detect viral particles and viral proteins based on a unique signal transduction mechanism and can be used for in situ measurements inside of the mouth or in saliva samples. The fact that no external reagents are required makes this approach particularly amenable to decentralized on-demand testing. Project deliverables will include a screening system that will allow for direct SARS-CoV-2 detection from a saliva sample (without the generation of aerosols) in a time frame relevant at-home community screening. This will accelerate the availability of high-quality and real-time data to support a rapid response to better detect and manage COVID-19. In addition, the low cost and portable nature of the diagnostic device will allow for deployment to low- and middle-income countries to help prevent the rapid spread of COVID-19 within those populations. The rapid viral detection system will: 1) Provide an alternative to PCR-based testing and accelerate the availability of high-quality diagnostic information to allow Americans to better manage the pandemic; 2) Develop an effective intervention that will provide rapid, actionable diagnostic information on COVID-19 status; 3) Enable clinical studies that assess viral load as a function of medical countermeasures by facilitating serial and continuous monitoring of patients for SARS-CoV-2.

项目摘要： COVID-19大流行强调了病毒感染现有测试方法的缺点。 使用PCR或其他扩增策略诊断主动感染受到集中测试的限制 容量有限的设施。新的护理点分子测试方法，同时提供一种手段 要在实验室外测试，吞吐量和周转时间较低，与 广泛的快速筛选。此外，鉴于鼻咽的使用是非常有问题的 难以获取和处理此样本类型。抗体测试集成到横向流动设备中 利用更可行的样本类型，可有效估计感染率，但对 检测主动感染。 在此提案中，我们描述了一种新的病毒检测方法，该方法是快速的，可以大规模分散 测试，并提供了一种进行病毒感染评估作为对抗电流的工具的新方法 COVID-19大流行并控制未来的病毒爆发。为这种方法提供动力的新技术是 使用电化学读数实现的无试剂传感的突破，这将使快速 筛查SARS-COV-2感染。传感器将基于 一种独特的信号转导机制，可用于嘴巴内部或IN内的原位测量 唾液样品。不需要外部试剂的事实使这种方法特别适合 分散的按需测试。 项目可交付成果将包括一个筛选系统，该系统将允许从A直接检测SARS-COV-2 唾液样本（不产生气溶胶），在相关的家庭社区筛查中。这 将加速高质量和实时数据的可用性，以支持快速响应以更好地检测 并管理Covid-19。此外，诊断设备的低成本和便携性性质将允许 部署到低收入和中等收入国家，以帮助防止Covid-19在这些国家的迅速传播 人群。 快速病毒检测系统将：1）提供基于PCR的测试的替代方案，并加速 提供高质量的诊断信息，使美国人能够更好地管理大流行； 2） 制定有效的干预措施，以提供有关COVID-19状态的快速，可行的诊断信息； 3）启用临床研究，通过促进串行来评估病毒载量与医学对策的关系 并连续监测患者的SARS-COV-2。